The disclosed embodiments relate generally to pricing medical diagnostics including, for example, medical diagnostics for determining whether a patient has or is likely to develop a disease, or the suitability of a therapeutic treatment. Methods and apparatus according to various embodiments are capable of, for example, pricing a medical diagnostic based on value created by the medical diagnostic.
Certain medical diagnostic tests (“diagnostics”) such as molecular diagnostic tests can be intended to be predictive of the efficacy, safety and/or response of particular therapeutic regimens. The Food and Drug Administration (“FDA”) may, for example, require the availability and use of a diagnostic test prior to administration and use of certain pharmaceutical therapies.
Such a requirement or clinical obligation for use of a companion diagnostic test before starting a drug regime presents a problem for drug manufacturers that do not currently control (e.g., own) and price the diagnostic (or intellectual property related to the diagnostic). The manufacturer of the diagnostic, for example, in order to maximize profit, has an incentive to price the diagnostic very high due to its high economic utility and one-time use. The manufacturers and/or distributors of therapeutic drugs (or other complementary products or therapeutic treatments) have an opposing pricing viewpoint. Such manufacturers and/or distributors would prefer that the diagnostic be priced low, such that more individuals can be tested and, subsequently, begin a therapeutic treatment utilizing the manufacturer's products.
Additionally, the typical usage profile of a diagnostic is a single use and the typical usage profile of a therapeutic treatment is ongoing use. Due to these different usage profiles, the combined economic value of the diagnostic and the therapeutic treatment may be greatest if the diagnostic has a low price. Thus, the high price of some diagnostics and low disease rates of the diseases for which the diagnostics test can make broad screening with diagnostics uneconomical even if the diagnostic is highly accurate.
Methods of pricing diagnostics are known. For example, one such method includes the price of a medical diagnostic in the average price of a comprehensive treatment of a condition indicated by the diagnostic. Thus, an individual who is tested with the medical diagnostic for a medical condition and undergoes a treatment for the medical condition will be charged the same price as other individuals receiving the diagnostic and treatment.
Some known pricing methods allow a user to pay a fixed cost of a medical diagnostic or medical treatment over a period of time. For example, a patient can make monthly payments on the cost of a medical diagnostic or medical treatment for a number of years to spread the cost of the diagnostic and/or treatment over time.
However, known diagnostic pricing methods fail to provide incentives for diagnostic manufacturers to price diagnostics such that the combined medical and/or economic value between a diagnostic manufacture and drug manufactures can be advantageously realized. Furthermore, known diagnostic pricing methods fail to encourage testing or screening of large populations to determine whether certain therapeutic treatments can be beneficial to individuals in these populations. Thus, a need exists for improved pricing methods for diagnostics.